Rock Creek Pharmaceuticals Inc., a wholly owned subsidiary of Star Scientific Inc.,  has received IRB approval of the first human clinical study of the safety and effects of nutritional supplementation with Anatabloc in individuals with Alzheimer's disease.

The study will be undertaken in conjunction with the Roskamp Institute of Sarasota, Florida, which has been acting as a research partner in assessing the impact of Anatabloc on Alzheimer's.

This study developed out of Roskamp's earlier research work published in the European Journal of Pharmacology (Paris D et al. Anatabine lowers Alzheimer's AB production in vitro and in vivo, Eur J Pharmacol. 2011 Nov 30;670(2-3):384-91) and multiple reports of use of the supplement in users with Alzheimer's disease. Both Rock Creek's and Roskamp's medical teams agreed that enough preliminary data was now available to initiate the study.

The study, entitled “A Three Month, Single-Site or Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease” is a six-visit, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the safety, tolerability, and potential effects of anatabine dietary supplementation in subjects with mild to moderate Alzheimer's disease (AD). Secondary aims are to evaluate the effects of this specially formulated version of Anatabloc (patent pending) on amyloid beta (AB), global outcome, and functional measures of AD. Although the Roskamp Institute will be the primary study site, it is anticipated other sites may be added as needed to fulfill enrollment goals.  The study will enroll subjects at least 65 years of age with a diagnosis of mild to moderate Alzheimer's disease, and it is expected that a minimum of 120 subjects will complete the trial.

Dr Ryan Lanier, chief clinical scientist for Rock Creek Pharmaceuticals, who coordinated the development of the study protocol, commented, “The Roskamp Institute has done its usual thorough job in working with Rock Creek to design a study that will begin to bring definitive answers to whether supplements of this class are tolerable and have demonstrable effects in supporting the medical treatment of individuals with this terrible condition. In answering calls from physicians looking for ways to support their patients suffering from Alzheimer's, it has been intensely frustrating to tell them that we are preparing for such a study, but have to complete the preliminary work to support a study in this population.  Doing good science takes time and patience, but I am very glad we have the data needed to get started. The work done by Roskamp to date has been of world-class quality and I am confident that the same quality will continue in its role as the primary site for the Alzheimer's study. We will do everything we can to support the Roskamp Institute in that effort.”

Rock Creek Pharmaceuticals and the Roskamp Institute have worked collaboratively on research relating to the company's anatabine compound for a number of years, occasioned by the Institute's interest in the effect of the compound on immune system support.  Inflammation and the proper or aberrant functioning of the immune system is a critical factor in a number of neurological disorders studied by the Institute, and helping the immune system regain its natural balance through nutrition is one path toward supporting current medical treatments for such conditions.

Paul L Perito, Rock Creek's chairman and CEO stated, “I have waited a long time for this pivotal event, with considerable anticipation. We strongly believe that our nutritional products will be of value to physicians in providing optimal care for their patients, and I'm going to make sure that we do everything we can to get this study done as fast as possible.”

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